1. Field of the Invention
This invention relates in general to the field of biomechatronics, and more particularly to a wireless intelligent prosthetic system having real time diagnostics and active user feedback.
2. Description of the Related Art
Prosthetics and prosthetic limbs have been used to replace human body since at least 1,000 B.C. Egyptian and Roman history is replete with recitations of wooden toes, iron hands and arms, wooden legs, feet and the like. However, it was not until the Renaissance that prosthetics began to provide for function (e.g., moving hands and feet) in addition to appearance. During this period the first prosthetic leg was developed having a suction socket that maintained a more effective and durable connection between a patient's residual limb and the leg.
Since that time, and particularly during the past 75 years, developments in the field of prosthetic devices have flourished in this country, particularly with the help of funding from the National Academy of Sciences, the Armed Services, the American Orthotics and Prosthetic Association, and other philanthropic entities. Beyond this country, The International Society for Prosthetics and Orthotics continues to foster both research and clinical practice worldwide.
In the 1980s, socket technology evolved from sockets made in the shape of a square bucket with no specialized adaptation to the specific size and shape requirements of the patient's residual limb to a socket that conformed to the patient's limb like a glove. With this advancement, patients were enabled to perform activities over and above simply walking—they were able to run, to walk both up and down stairs, and to step over substantially large objects. Today, amputees even compete in sports activities. And the pull on developers continues in this field as a result of these ever increasing needs.
Many patients are able to maintain a sufficient attachment of their limb to their prosthesis merely as a result of the good fit between a conforming socket and the limb, that is, gravity and friction do a good enough job of keeping the socket and prosthesis attached. However, there is a class of patients for whom maintaining an effective bond between limb and socket is a continual and ever evolving challenge. For some in this category, loss of “fit” is a result of changes in the size and shape of their residual limb. For others, the weight of the prosthesis relative to the residual limb precludes a good bond during activity. And for others, changes in their type of activity (e.g., running versus walking) cause the coupling between socket and limb to degrade.
It is for this class above that vacuum assisted devices and sockets have been more recently fielded. With a vacuum assisted prosthetic, the patient's limb is shielded with a protective cover such as a silicone liner over the top of which is placed a porous fabric sleeve, and the limb is inserted into a vacuum assisted socket. Through an air port in the socket, a vacuum pump is attached that is used to create a vacuum between the limb and the socket to enable the socket to be more effectively coupled to the limb. There are numerous developments in this field to include one-time external pumps, pumps that are carried by the patient, and pumps that are affixed to the exterior of the socket or to the prosthesis itself. Some pumps are manually operated. Other pumps are electronically activated either via a special activator (e.g. RF fob) or by control functions designed therein. Still other pumps provide a rudimentary form of automation that maintains a predetermined negative air pressure inside the socket cavity. Of these more advances pumps/controllers, some are able to gather limited data regarding wear which can be accessed through the use of special test equipment typically at a prosthetic specialist's facility. Most of the fit and wear data to date, however, is obtained through personal interview with the patient.
The present inventors have noted numerous limitations resulting from the state of the art including the requirement for special equipment requirements to both operate and access data captured by today's pumps/controllers. In addition, because these devices are either carried or mounted external to a prosthetic socket, additional manufacturing requirements are imposed on a socket (e.g., ports for connection of air hoses and electrical leads), and the pumps/controllers themselves are subject to damage due to their exposure to contaminants and unanticipated accidents. Furthermore, the present inventors have observed that the amount of data that is currently gathered by these devices is woefully lacking. As a result, the patient's prosthetic experience is problematic.
Accordingly, what is needed is an intelligent prosthetic socket system that can relay real time information to patients, where the information is derived from a series of sensors and data collection components.
Additionally, what is needed is a prosthetic socket system that includes an intelligent pump/controller that is disposed inside of a socket and that comprises a plurality of sensors for purposes of continually adjusting a vacuum between a residual limb and the socket.
Also what is needed is a prosthetic socket system including an intelligent pump/controller disposed inside of a prosthetic socket that gathers data related to fit and usage of an associated prosthesis.
Furthermore, what is needed is an intelligent pump/controller internal to a prosthetic socket that communicates information wirelessly to/from a commercially available “smart” device such as an IPHONE®, IPAD®, IPOD TOUCH®, or DROID®, where information from the smart device can be provided over the Internet for access by the user and authorized agents such as prosthetic fitters and medical personnel.
Moreover, what is needed is an intelligent pump/controller internal to a prosthetic socket that communicates information wirelessly to/from a multifunctional “smart” device that allows for a much broader and extensible set of controls and displays over that which has heretofore been provided.